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Gabapentin + Tizanidine for Insomnia in Chronic Pain

Phase 2
Waitlist Available
Led By Nathaniel Schuster, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a chronic pain condition (≥ 3 months of pain)
Reports sleep disturbance and scores ≥ 6 on AIS questionnaire
Must not have
Has diagnosis of chronic kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monday after 3 nights of drug intake
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing whether gabapentin or tizanidine can help improve insomnia in people with chronic pain.

Who is the study for?
This trial is for English-speaking individuals with chronic pain lasting over three months, a BMI of 35 or less, and trouble sleeping as shown by an AIS score of 6 or more. It's not for pregnant or breastfeeding women, those with kidney disease, heart rhythm issues (QT prolongation), allergies to the drugs being tested, shift workers, people who can't do daily surveys or might have jetlag during the study.
What is being tested?
The trial is testing if gabapentin and tizanidine help with sleep problems in people with long-term pain. Participants will be randomly assigned to receive either one of these drugs or a placebo without knowing which they're getting. The effects on their sleep will then be compared.
What are the potential side effects?
Gabapentin may cause dizziness, fatigue, and swelling in hands/feet. Tizanidine can lead to dry mouth, muscle weakness, low blood pressure when standing up too fast. Both could potentially affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been in pain for 3 months or more.
Select...
I have trouble sleeping and my sleep issues score is 6 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with chronic kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monday after 3 nights of drug intake
This trial's timeline: 3 weeks for screening, Varies for treatment, and monday after 3 nights of drug intake for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep quality
Secondary study objectives
Alertness
Categorical assessment of insomnia improvement
Overall improvement
+1 more

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tizanidine 2mgExperimental Treatment1 Intervention
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Group II: Gabapentin 300mgExperimental Treatment1 Intervention
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Group III: PlaceboPlacebo Group1 Intervention
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved
Tizanidine
FDA approved

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
365 Previous Clinical Trials
412,590 Total Patients Enrolled
1 Trials studying Insomnia
102 Patients Enrolled for Insomnia
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,032 Total Patients Enrolled
2 Trials studying Insomnia
53 Patients Enrolled for Insomnia
Nathaniel Schuster, MDPrincipal InvestigatorUC San Diego

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04429347 — Phase 2
Insomnia Research Study Groups: Placebo, Gabapentin 300mg, Tizanidine 2mg
Insomnia Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT04429347 — Phase 2
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04429347 — Phase 2
~5 spots leftby Nov 2025
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